2
07
111100000000271742
北京市药品监督管理局
对“药品出口销售证明”的出具
1111000000002717422110746002000
0
b3c4bb3c-743e-4537-bfdd-2dccd6814279
34f0da2a-0768-452e-957a-95ba2a37e57c
2
07
市药监局
110000000000
北京市药品监督管理局
工作日8:30-17:30（8:30-9:00、12:00-13:30、17:00-17:30为延时服务时间）、周六9:00-13:00（周六为延时服务时间，需预约办理）、法定节假日不对外服务。
北京市政务服务中心：北京市丰台区西三环南路1号(六里桥西南角)(1-3层综合窗口)
北京城市副中心政务服务中心：北京市通州区新华东街48号二区（东南角）（综合窗口）
第三条 由各省、自治区、直辖市药品监督管理部门负责本行政区域内《药品出口销售证明》出具办理工作（已批准上市的药品的式样见附件1，已批准上市药品的未注册规格的式样见附件2，未在我国注册的药品的式样见附件3）。 第四条 药品上市许可持有人、药品生产企业办理药品出口销售证明的，应当向所在地省级药品监督管理部门提交《药品出口销售证明申请表》（式样见附件4）。 对于已批准上市的药品、已批准上市药品的未注册规格，应当分别提交相应的《药品出口销售证明申请表》，同时提交以下资料： （一）药品上市许可持有人证明文件或者药品生产企业的《药品生产许可证》正、副本（均为复印件）； （二）已批准上市药品的药品注册证书（复印件）； （三）境内监管机构近3年内最近一次相关品种接受监督检查的相关资料（均为复印件）； （四）《营业执照》（复印件）； （五）按照批签发管理的生物制品须提交《生物制品批签发合格证》（复印件）； （六）申请者承诺书； （七）省级药品监督管理部门另行公示要求提交的其他资料。 对于未在我国注册的药品，提交《药品出口销售证明申请表》的同时，提交以下资料： （一）药品上市许可持有人证明文件或者药品生产企业的《药品生产许可证》正、副本（均为复印件）； （二）与我国有相关协议的国际组织提供的相关品种证明文件（原件）； （三）《营业执照》（复印件）； （四）境内监管机构近3年内最近一次生产场地接受监督检查的相关资料（复印件）； （五）申请者承诺书； （六）省级药品监督管理部门另行公示要求提交的其他资料。 所有以复印件形式提交的材料需加盖申请者的公章，内容应当真实准确。（来源：关于印发药品出口销售证明管理规定的通知） 1．申请材料应扫描成电子版，内容完整、清晰，按要求签字并加盖企业公章。
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2
2
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